CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 78 target
Drug / intervention
ZG006biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06440057
NCT06440057Phase 2RecruitingMonitorUpdated 18mo ago · Completion was 2mo ago
Slow Enrollment
Monitor

A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Neuroendocrine Carcinoma.

Suzhou Zelgen Biopharmaceuticals Co.,Ltd·interventional·Posted Jun 3, 2024·Updated Dec 16, 2024

In Brief

A Phase 2 clinical trial evaluating ZG006 for Neuroendocrine Carcinoma. Currently recruiting, targeting 78 participants across 1 site.

Signals

Enrolling slower than its timeline implies

Detailed Summary

This is a multicenter, open-label phase I/II study, divided into 2 parts: Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2. Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2RecruitingOverdue
20252026
First PostedJun 3, 2024
Enrollment StartAug 29, 2024
Primary CompletionMay 1, 2026
Study CompletionJul 1, 2026
TodayJul 1, 2026
Enrollment to primary: 1.7 yearsPosted 2.1 years ago

Interventions

ZG006biological

ZG006 will be administered as an intravenous (IV) infusion.